Kornimate/medical-research-clean huggingface dataset:
pharmacodynamic effects of anti-vascular endothelial growth factor therapy in patients with advanced malignancies

Conditions: Hypertension; Proteinuria

Summary: 1. to determine the effect of anti-vascular endothelial growth factor (vegf) on endothelial function and on retinal microvasculature 2. to determine endothelial dysfunction as a marker of early response and as an indicator for the development of hypertension and proteinuria in patients treated with anti-vegf agents 3. to characterize the effect of anti-vegf therapy on the pulmonary function of patients with malignancy (primary or secondary) involving the lung

the well-established role of vascular endothelial growth factor (vegf) in carcinogenesis and tumor angiogenesis has led to the development of agents that target this pathway. anti-vegf agents the vegf monoclonal antibody bevacizumab, and the small molecule vegf receptor tyrosine kinase inhibitors. angiogenic factors play a key role in the maintenance of lung integrity and normal endothelial function. endothelial dysfunction has been implicated in hypertension, proteinuria and retinopathy. one of the major issues of anti-vegf agents is its long-term toxicity especially taking into account the lack of adequate knowledge in this area and the possibility of prolonged periods of therapy in non-progressing patients. hypertension and proteinuria are commonly seen in patients treated with anti-vegf agents. in addition, we have also observed in a relatively high frequency of pulmonary air-filled lesions in patients with malignancy in the lung treated with an anti-vegf agent. objectives of this exploratory study are to 1) determine the effect of anti-vascular endothelial growth factor (vegf) on endothelial function 2) determine endothelial dysfunction as a marker of early response and as an indicator for the development of hypertension and proteinuria 3) characterize the effect of anti-vegf therapy on the pulmonary function of patients with malignancy (primary or secondary) involving the lung in patients treated with anti-vegf agents. pharmacodynamic endpoints to be assessed are: blood pressure, brachial artery reactivity, retinal microvessels, microalbuminuria and proteinuria, pulmonary function, assess the effects of anti-vegf therapy by assessing brachial artery reactivity, retinal vasculature and pulmonary function in a subset of patients receiving anti-vegf therapy. the development of markers of endothelial dysfunction may result in the early identification of patients who are non-responders or develop toxicity from anti-vegf treatment.

Eligibility criteria:
inclusion criteria: * patients who are receiving single agent anti-vegf therapy * signed written informed consent. * patients with measurable pulmonary malignancy (primary or metastatic) as determined by recist will undergo assessment of pulmonary function. * patients with a known allergy to intravenous contrast used in fluorescein and indocyanine green angiography will be exempt from these investigations but will undergo other study assessments exclusion criteria: * none
a phase ii study of iressa in patients with chemo refractory germ cell tumors expressing egfr

Conditions: Refractory Germ Cell Tumors Expressing EGRF

Summary: this study will evaluate the use of zd1839 in the treatment of subjects with refractory germ cell tumors. subjects will take zd1839 for one year in the absence of excessive toxicity or decision to withdraw.

the primary objective is to determine the response rate of zd1839 in patients with refractory germ cell tumors expressing egfr. the secondary objectives are to determine the duration of response, time to progression and overall survival in patients with refractory germ cell tumors expressing egfr and treated with zd1839; to evaluate the tolerability of zd1839 in patients with refractory germ cell tumors and to correlate tumor response to degree of egfr expression by immunohistochemistry.

Eligibility criteria:
inclusion criteria: * histologic or serologic proof of metastatic germ cell neoplasm(gonadal or extragonadal primary) with disease not amenable to cure with either surgery or chemotherapy. patients w/ seminoma and non-seminoma are eligible, as are women w/ ovarian germ cell tumors. * evidence of recurrent or metastatic carcinoma * must have received initial cisplatin combination therapy \& demonstrated progression following the administration of at least one "salvage" regimen for advanced germ cell neoplasms. * patients are eligible after first line platinum bsed chemotherapy if their disease has relapsed and they have primary mediastinal non seminomatous germ cell tumor, late relapse or progressed w/in 4 wks of last platinum dose. * immunohistochemical documentation of egfr expression documented. * adequate organ function: anc \>/=150,plt \>100k, total bili \</= upper limit of normal(uln). pts w/ liver mets up to 3x uln.transaminases up to 1.5 x uln if alk phos is \</=uln or alk phos may be up to 4x uln if transaminases are \</= uln. pts w/ liver mets may have alk phos up to 5x uln. serum crt \</= 2.0. * ecog performance status 0-2. exclusion criteria: * must be 3 weeks post major surgery, radiotherapy, or chemotherapy and hae recovered from all toxicity. * active unresolved infection and/or are receiving concurrent treatment with parenteral antibiotics are ineligible. * patients requiring steroids for symptomatic brain metastasis are not eligible. * pregnant or lactating patients are not eligible. * class iii/iv heart disease

Keywords: refractory germ cell tumors germ cell tumors
tissue markers predictive of early stenosis in the arterovenous fistula for hemodialysis

Conditions: AV Fistula

Summary: the study involves the recruitment of two populations. population 1 (surgical sample of excess venous segment): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to first avf surgery as part of the normal care pathway, at the metropolitan vascular surgery unit, dir. prof. mauro gargiulo of the s.orsola-malpighi university hospital. population 2 (surgical sample of arterialized venous segment from removal of previous avf): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to reoperation for correction of complication and/or new avf by proximalization, as part of the normal care pathway, at the metropolitan vascular surgery unit, dir. prof. mauro gargiulo of the s.orsola-malpighi university hospital.

the following study will enroll two cohorts of patients: 75 patients from population 1 and 75 patients from population 2, according to the inclusion criteria. since this is an exploratory study, this number is considered sufficient to observe and compare tissue markers associated with early avf stenosis. patients will be treated according to clinical practice in accordance with the physician's judgment. the study includes: the recruitment of patients from the two study populations, the obtaining of the surgical specimen from both populations and its sending to the pathology department, as part of the normal care pathway, the execution of three tissue samples at the pathology department: (i) a sample frozen in liquid nitrogen and stored in an ultrafreezer at -80°c for rt-pcr analysis; (ii) a sample placed in pbs for cell culture; (iii) the remainder of the sample fixed in formalin, embedded in paraffin and processed according to the normal care pathway and histological diagnosis. 2 µm slices will be cut from the paraffin block for histological staining and histochemical and iic investigations; execution of cell culture investigations and execution of rt-pcr investigations.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years; * patients candidates for first avf for hemodialysis or correction of avf complication, as part of the normal care pathway; * obtaining informed consent signed by the patient exclusion criteria:
endometrial follicular fluid flushing and ivf outcome

Conditions: Clinical Pregnancy

Summary: objective: in this study, our aim will be investigating the pregnancy results in unexplained infertile women undergoing icsi, by flushing the endometrial cavity with folliculer fluid, that we maintain mature follicules inside them in oocyte retrieval day. study design: 100 subfertile women who applied to zeynep kamil hospital, in vitro fertilization center between october 2016 to may 2017 will be randomized with computer generated programme. the patients will be divided into two groups; follicular fluid group (n=50) and control group (n=50). the inclusion criterias are: age between 20-39 years, basal fsh level \< 10 miu/ml, body mass index\<35 kg/m2 and e2 levels in human chorionic gonadotropin (hcg) day between 1000-4000 pg/ml. patients meets these criteria will be included to the study programme. the exclusion criteria are determined as below: previously diagnosed endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history of implantation failure in ivf/icsi cycles and severe male factor infertility.

objective: in this study, our aim will be investigating the pregnancy results in unexplained infertile women undergoing icsi, by flushing the endometrial cavity with folliculer fluid, that we maintain mature follicules inside them in oocyte retrieval day. study design: 100 subfertile women who applied to zeynep kamil hospital, in vitro fertilization center between october 2016 to may 2017 will be randomized with computer generated programme. the patients will be divided into two groups; follicular fluid group (n=50) and control group (n=50). the inclusion criterias are: age between 20-39 years, basal fsh level \< 10 miu/ml, body mass index\<35 kg/m2 and e2 levels in human chorionic gonadotropin (hcg) day between 1000-4000 pg/ml. patients meets these criteria will be included to the study programme. the exclusion criteria are determined as below: previously diagnosed endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history of implantation failure in ivf/icsi cycles and severe male factor infertility.

Eligibility criteria:
inclusion criteria:age between 20-39 years, basal fsh level \< 10 miu/ml, body mass index\<35 kg/m2 and e2 levels in human chorionic gonadotropin (hcg) day between 1000-4000 pg/ml. - exclusion criteria:previously diagnosed endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history of implantation failure in ivf/icsi cycles and severe male factor infertility. -
home blood pressure monitoring project

Conditions: Hypertension

Summary: the goal of this project is to improve hypertension control at kaiser permanente colorado (kpco) by implementing a population-based multi-factorial intervention that uses home bp monitors that can download bp readings to kpco's health records via internet, interactive voice response (ivr) technology, and multidisciplinary care team. participants will be randomized to either the home blood pressure monitoring group receiving the multi-factorial intervention or the usual care group who will be receiving kaiser standard of care. we will determine the proportion of patients in each group who achieve their target bp goals at 6 months, according to national clinical practice guidelines. the study hypothesis is that a higher proportion of patients with uncontrolled hypertension in the home blood pressure monitoring (hbpm) group will achieve their target blood pressure compared to those in the usual care (uc) group.

study objectives: primary: • to determine the proportion of patients in each group who achieve their target bp goals at 6 months, according to national clinical practice guidelines secondary: the following parameters will be evaluated between groups: * change in bp measures between baseline and at 6 months * proportion of patients who are receiving antihypertensive treatments in accordance to national clinical practice guidelines * adherence to hypertensive medication regimen during the 6-month follow-up period * patient satisfaction with the care model.

Eligibility criteria:
inclusion criteria: * age 18 to 85 years at least 1 diagnosis for hypertension, * receive primary care from one of the participating clinics, * the two most recent bps documented within that last 24 months are elevated (sbp\>140 and/or dbp\>90) * receiving \< 3 antihypertensive medications, and * have access to a computer with a usb port. exclusion criteria: * pregnant, or breast-feeding, * patients on dialysis or being followed by nephrology, * patients with coronary artery disease, given these patients are already followed by the clinical pharmacy cardiac risk service (cpcrs), * on kpco "do not call" or deceased list, * pcp does not give permission to include patient in the study, * bp is at or below target at the baseline study visit, * not english-speaking.

Keywords: hypertension, intervention
the effect of sugammadex on the outcome after colorectal cancer surgery

Conditions: Outcome, Fatal

Summary: this study is retrospective study. the purpose of this study is checking the effect of sugammadex on the outcome after colorectal surgery. the outcome is compared among the 2 groups, sugammadex group and non-sugammadex group. the primary parameters of outcome are length of stay, readmission rate, postoperative complications, time interval for first successful oral intake.

abdominal surgery, like colorectal surgery, needs more than moderate neuromuscular block during surgery. after the surgery, reversal agent of neuromuscular blocking agent is given almost every pateints who underwent general anesthesia. classic reversal agent is cholinesterase inhibitor, like pyridostigmine and neostigmine. its action mechanism is competetive antagonist of rocuronium. but cholinesterase inhibitor cannot make complete reversal in moderate or deep neuromuscular block. its incomplete reversal which is called residual block cause respiratory complications and prolongation hospital stay. sugammadex has different mechanism compared to cholinesterase inhibitor. it captures neuromuscular agent, especially rocuronium, and prevent rocuronium's action. even in deep neuromuscular block, sugammadex can reverse the action of rocuronium, and its reversal effect is fater and more reliable compared to cholinesterase inhibitor. previous studies focused on only short term outcome of sugammadex, like postanesthetic care unit (pacu) discharge time, respiratory complications in pacu. but in this study, longer term outcome will be comapred between sugammadex group and cholinesterase inhibitor group (pyridostigmine).

Eligibility criteria:
inclusion criteria: * subjects aged 21\~80 * subjects who took colorectal surgery due to colon or rectal cancer from jan, 2012 to dec, 2017 exclusion criteria * emergency surgery * paraplegia or quadriplegia * bedridden state d/t various reason * neuromuscular disease * combined operation wth other surgery

Keywords: sugammadex colorectal surgery postoperative complication
visual function, center point thickness and macular volume after photocoagulation

Conditions: Diabetic Retinopathy; Macular Edema

Summary: the purpose of this study is to correlate changes of visual function three weeks after photocoagulation for macular edema, with changes of center point thickness and macular volume.

photocoagulation for clinically significant macular edema is effective to reduce the incidence of moderate visual loss. selective photocoagulation for focal macular edema statistically reduces macular thickening, measured with optical coherence tomography, as early as two weeks after treatment, without significant changes over center point thickness. although anatomic improvement has been demonstrated with oct, clinical improvement takes longer to be evident: the early treatment diabetic retinopathy study describe that clinical differences in visual function are after the eight month, and all the treatment strategies for macular edema used in this study were associated with an increased rate of moderate visual loss, during the first six weeks. differences in research can achieve statistical significance, without clinical significance. a study was conducted to identify changes of visual function three weeks after photocoagulation for focal macular edema, and to correlate them with changes of cpt and macular volume, in order to compare the behavior of anatomical changes with visual changes.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * regardless of diabetes duration and retinopathy severity level * one or both eyes with focal clinically significant macular edema * treated with selective or focal photocoagulation * visual capacity under subjective refraction before and three weeks after treatment * adequate quality 6 mm fast macular map both on the day of photocoagulation, and three weeks after it exclusion criteria: * patients with myopia over -6.00 diopters * any retinal disease different from diabetic retinopathy at the moment of photocoagulation * eyes with a thickened posterior vitreous * eyes with vitreoretinal traction at the macula * if they had required scatter photocoagulation before the three weeks evaluation

Keywords: center point thickness diabetic retinopathy diabetic macular edema macular volume visual capacity visual function
soundbite hearing system 24 month multi site patient use study

Conditions: Single Sided Deafness; Conductive Hearing Loss

Summary: the objective of this multi-site observational study is to further assess the long-term patient use of the sonitus soundbite hearing system. information can be gained by assessing benefit for the subjects that were enrolled in the soundbite hearing system long term multi site study (protocol cln006) for an additional 12 months.


Eligibility criteria:
inclusion criteria: * subjects who previously were enrolled in soundbite hearing system long term multi site patient use study (protocol cln006) and completed the 12 month study visit. * additionally, subjects must meet one of the two criteria for hearing loss: 1. moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or "ssd"). normal hearing is defined as a pure tone average (pta) air-conduction (ac) hearing threshold (measured at 0.5, 1, 2, and 3 khz) of better than or equal to 25 db hl. or 2. conductive hearing loss where the pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 khz) is better than or equal to 25 db hl. exclusion criteria: * subjects that do not meet one of the two the audiometric criteria as measured on the audiogram for the 12 month study appointment for protocol cln006: 1. a moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or -ssd‖). normal hearing is defined as a pure tone average (pta) air-conduction (ac) hearing threshold (measured at 0.5, 1, 2, and 3 khz) of better than or equal to 25 db hl. 2. patients with conductive hearing loss where the pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 khz) is better than or equal to 25 db hl * the soundbite hearing system and all portions of it are contraindicated for use in an mri environment and should be removed prior to mri exposure * the soundbite hearing system is not to be used in patients with known hypersensitivity to any of the components including allergies to polymers. * the soundbite hearing system is contraindicated for vulnerable populations that are unable to use their hands such as paraplegics or others that are unable to comply with the warnings in the product's labeling.

Keywords: single sided deafness conductive hearing loss unilateral hearing loss ssd
a prognostic transcriptomic signature for chronic hypersensitivity pneumonitis

Conditions: Hypersensitivity Pneumonitis

Summary: up to 150 patients with hypersensitivity pneumonitis will be enrolled at 7 clinical centers across the united states. patients will be followed for 24 months to determine if biomarkers in the blood can predict disease progression.

hypersensitivity pneumonitis is an immunologically mediated form of lung disease, resulting from inhalation exposure to a large variety of antigens. for unknown reasons, a subgroup of patients with hp without a known inciting antigen exposure develops chronic disease with progressive pulmonary fibrosis (the leading cause of death). accurately identifying patients at risk of disease progression is necessary for prognosis and therapy. enrolled subjects will be followed for 24 months and complete 5 visits to one of the study centers. blood biomarkers will be collected in addition to other clinical data to determine if these biomarkers can predict disease progression.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic hypersensitivity pneumonitis * age 18 through 85 years. * diagnosis of chronic hypersensitivity pneumonitis by hrct * able to understand and sign a written informed consent form. * able to understand the importance of adherence to the study protocol and willing to follow all study requirements exclusion criteria: * not a suitable candidate for enrollment or unlikely to comply with the requirements of this study * known explanation for the interstitial lung disease * clinical diagnosis of any connective tissue disease * listed or expected to receive a lung transplant within 4 months from enrollment * pregnant women
effects of moderate exercise and interval exercise on sleep quality

Conditions: Exercise Addiction; Control Condition

Summary: this study aimed to explore the effects of a single bout of moderate- aerobic continuous exercise (mace) and high-intensity intermittent exercise (hiie) on sleep during continuous night shifts in medical shift workers with mild sleep impairment.

medical staff with sleep disturbances due to their night-shift work were randomized to either a treadmill walking session for 47 minutes with moderate intensity (the heart rate reaches 70\~75% of the maximum heart rate), treadmill running section for 28 minutes with intermittent high-intensity (the heart rate reaches 90\~95% of the maximum heart rate for 4 minutes and 50\~70% for 3 minutes), or a quiet-rest control, 14 hours before undertaking a continuous night shift. sleep quality was assessed by actigraph with subjective questionnaire for 1 night and 3 nights after exercise. tests were performed (t-tests or χ2 tests) to test for differences between any two of the three intervention trials.

Eligibility criteria:
inclusion criteria: * medical staff who have worked at least three consecutive night shifts * reporting sleep disturbed during the night shift * not taking sleep/psychotropic medications * no clinical diagnosis of sleep apnea or other sleep disorder * not exercising regularly exclusion criteria: * not medical staff * without night shift * taking sleep/psychotropic medications * exercising regularly

Keywords: heart rate variability sleep quality
vasoactive hormones during the night in patients with obstructive sleep apnea before and after treatment with cpap.

Conditions: Obstructive Sleep Apnea

Summary: we wanted to test the hypothesis that treatment with continuous positive airway pressure reduces nocturnal hypoxia and thereby affecting levels of vasoactive hormones leading to a fall in blood pressure patients with obstructive sleep apnea.


Eligibility criteria:
inclusion criteria: * age between 20 and 65 years * obstructive sleep apnea * hypertension or normal blood pressure exclusion criteria: * drug or alcohol abuse * pregnancy * history or clinical signs of disease in the heart, lungs, brain,liver, kidneys or endocrine organs * diabetes

Keywords: obstructive sleep apnea hypertension vasoactive hormones